Kornimate/medical-research-clean huggingface dataset:
the objectives of the cartilage repair registry is to report long term efficacy and safety of cartilage repair procedures in registry patients

Conditions: Articular Cartilage; Cartilage Diseases

Summary: the objectives of the cartilage repair registry is to report the long term efficacy and safety of cartilage repair procedures in registry patients.


Eligibility criteria:
inclusion criteria: * all registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort exclusion criteria: * all registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort
pirfenidone as treatment of skin fibrosis in systemic sclerosis

Conditions: Systemic Sclerosis

Summary: this study is to evaluate the efficacy and safety of an antifibrotic agent, pirfenidone as treatment of systemic sclerosis. the primary outcome of this study is improvement of skin fibrosis.

all patients enrolled should suffer from moderate to severe skin fibrosis at the screening stage. the study period is 52 week. the study contains two stages, a 24-week blind stage following with open stage for another 24-week period of time. subjects will receive pirfenidone or placebo randomized in the first 24-week and will all receive pirfenidone treatment in the second 24-week, with of combination of low dose steroids. the secondary outcomes of this study include but not limit to safety, improvement of lung fibrosis and digital ulcer burden.

Eligibility criteria:
inclusion criteria: * fulfill eular/acr classification criteria (2013) for systemic sclerosis (ssc). * subjects must have mrss≥10 at screening stage * subjects must have signs of fibrosis in their chest ct at screening stage * if a subject has received treatments before, it should be stable at least 3 months until screening and with no significant efficacy (δmrss≤-2) exclusion criteria: * subjects with other connective tissue diseases overlapping with ssc * subjects with skin atrophy as the main cutaneous manifestation * subjects with active digital ulcers or gangrene * active severe ssc-driven renal disease or heart dysfunction at screening * subjects with significant hematologic abnormalities * abnormal liver function test at screening (alt, ast or total bilirubin over 2 fold of upper normal level * clinically significant active infection including ongoing and chronic infections * history of human immunodeficiency virus (hiv) * confirmed positive tests for hepatitis b or positive test for hepatitis c * active tuberculosis * live or attenuated vaccine within 4 weeks prior to screening * subjects with significant hematologic abnormalities
primebrain stimulation

Conditions: Preterm Infants

Summary: background : brain vulnerability is particularly marked in preterm neonates and has long-term consequences. unlike lesions affecting other organs, those that affect the brain can currently not 'be repaired' by producing new cells. however, exeprience-driven brain plasticity allows the brain to reorganise its connections to compensate (at least partially) the effects of an injury. purpose : to evaluate the influence of primebrain stimulation programme administred by parents until 6 months post-term on motor and neurophysiological development of infants born \<32 weeks' gestation or with birth weight \<1500 g.

preterm and very low birth weight infants are at risk for neurodevelopmental disorders, including cerebral palsy, sensory impairment and intellectual disability. several early intervention approaches have been designed in the hope of optimising neurological development in this context. these programmes show high variety in the type of intervention, frequency of sessions and total duration of the intervention, as well as the duration of follow-up. depending on studies, there is an inconstant benefit on cognitive and behavioural development in the first 2 years and preschool age. according to the most recent studies, it seems important that the intervention takes into account parental mental health, focuses on parent-child interactions and lasts sufficiently long. this prospective randomized-controlled clinical study has been designed to evaluate the effects of an additional parent-administed programme to the usual care in this developmental risk population,. the intervention is carried out at home by parents coached by physiotherapist from term-age to 6 months of corrected age. the monitoring and evaluation period for all infants participating in the study ends at 24 months of corrected age and includes clinical, neurodevelopmental, parental stress and neurophysiological assessments using high density electroencephalography and recording of event-related potentials at term age, 3, 6, 12 ,18 and 24 months of corrected age (activetwo, biosemi).

Eligibility criteria:
inclusion criteria: * infants born before 32 weeks of gestation or with a birth weight less than 1500 grams exclusion criteria: * severe congenital malformation (cerebral, cardiac or within a syndrome) * neurodevelopmental genetic syndrome * cytomegalovirus, rubella or toxoplasmosis congenital infection * neonatal hypothyroidism * peripheral neurological disorder or congenital muscular disorder * neurodegenerative disorder
safety and efficacy of tki258 in relapsed or refractory multiple myeloma patients, who are with or without t(4;14) chromosomal translocation

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: this study will evaluate safety and efficacy of tki258 in patients with relapsed or refractory multiple myeloma


Eligibility criteria:
inclusion criteria: 1. cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment. 2. evidence of relapsed or refractory disease as documented from the prior treatment history. (refractory myeloma is defined as disease that is non-responsive while on salvage therapy, or progresses within 60 days of last therapy. relapsed myeloma is defined as previously treated myeloma which after a period of being off-therapy requires the initiation of salvage therapy. detailed definitions provided in the pts-1) 3. have received at least 2 prior treatment regimens for multiple myeloma including chemotherapy, autologous transplantation, immunotherapy, or other investigational agents. pre-planned induction, followed by transplant and maintenance should be considered as one regimen. 4. presence of measurable disease as defined by at least one of the following; * serum m-protein ≥ 1g/dl (measurable disease) * urine m-protein ≥ 200mg/24 hours by protein electrophoresis (measurable disease) exclusion criteria: 1. patients with non-secretory, or oligosecretory, multiple myeloma. 2. patients with symptomatic amyloidosis, or with plasma cell leukemia. 3. patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versus-host disease that requires immunosuppressive therapy. other protocol-defined inclusion/exclusion criteria may apply

Keywords: multiple myeloma relapsed refractory t(4;14) fgfr3
standard vs high-dose trivalent inactivated flu vaccine in adult hematopoetic stem cell transplant (hsct) recipients

Conditions: Adult Stem Cell Hematopoetic Transplant

Summary: hypothesis 1: the safety profile in adult allogeneic stem cell hematopoietic transplant (sct) recipients after high dose (hd) trivalent inactivated influenza vaccine (tiv) will not be significantly different from adult stem cell transplant recipients receiving standard dose (sd) tiv. * specific aim 1: to compare safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic stem cell transplant recipients. hypothesis 2: adult stem cell transplant recipients who received the higher dose trivalent influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody titers to influenza antigens compared to those who receive standard dose trivalent influenza vaccine. * specific aim 2: to compare humoral immune responses of adult hematopoietic stem cell transplant recipients influenza virus antigens included in trivalent influenza vaccine after high dose or standard dose trivalent influenza vaccine.


Eligibility criteria:
inclusion criteria: * allogeneic hematopoietic stem cell transplant recipients who are \>6 post-transplant * greater than or equal to 18 years of age * available for duration of study * if patients are on immunosuppressive therapy for treatment of graft versus host disease (gvhd): only those on stable doses for at least 4 weeks or on tapering doses will be eligible. exclusion criteria: * history of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein * history of guillain-barre syndrome * evidence of hematologic malignancy or disease relapse post-transplant (mixed chimerisms and molecular evidence of disease is permitted) * non-allogeneic (e.g. autologous) hematopoietic sct recipients * history of receiving 2011 - 2012 influenza vaccine * history of proven influenza disease after september 1, 2011. * pregnant females * have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol * have any condition that the investigator believes may interfere with successful completion of the study * platelet count less than 50,000 cells/μl * history of known infection with hiv, hepatitis b or hepatitis c * history of known latex hypersensitivity
success (selution, safety, efficacy, health economics and proms) pta study

Conditions: Peripheral Artery Disease

Summary: open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the selution slr™ (sustained limus release) drug eluting balloon (deb).

open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the selution slr™ (sustained limus release) drug eluting balloon (deb). this study will capture data from the use of the selution slr according to its approved labelling. each indication for use will have a specific data sets in addition to generic data sets that are common across all indications. patients will be followed for 5 years post-procedure to obtain safety and efficacy data. a health economic analysis will be made comparing data between countries within the study and to published data for existing treatment options. generic and disease specific patient reported outcome measures (proms) will be used to measure the impact of the intervention on the overall health status of patients. imaging data collection for patients whose standard of care includes imaging follow-up will be captured and analysed. data will be collected from any subject who receives a ce marked device for treatment of a peripheral (i.e. non-cardiovascular) vascular lesion. data analysis will be stratified by lesion location.

Eligibility criteria:
inclusion criteria: * subject age is ≥ 18 years * subject is able and willing to provide informed consent * subject is suitable for treatment with a medalliance selution slr deb according to the current instruction for use. exclusion criteria: * in the opinion of the treating investigator the subject has a life expectancy of less than 12 months * in the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime
safety and efficacy study of conbercept in diabetic macular edema (dme) (sailing)

Conditions: Diabetic Macular Edema

Summary: this study is designed to assess safety and efficacy of intravitreal injection of conbercept on visual acuity and anatomic outcomes in patients with diabetic macular edema (dme) .


Eligibility criteria:
inclusion criteria: 1. patients sign informed consent, and are willing and able to comply with all the follow-ups; 2. age ≥ 18 years , both genders; 3. diagnosis of type 1 or type 2 diabetes mellitus; 4. serum hba1c ≤ 10%; 5. study eye must meet the following criteria: * visual acuity impairment caused by dme with involving foveal; * bcva score ≥ 24 and ≤ 73 early treatment diabetic retinopathy study (etdrs) letters at 4 meter/1 meter of etdrs test(equivalent snellen chart 20/40 to 20/320); * visual impairment due to choroidal neovascularization (cnv) secondary to high myopia. * central retinal thickness (crt) ≥300μm (spectral domain optical coherence tomography (oct), the crt measurements must be confirmed by central reading center); * refractive media opacities and miosis have no effect on the fundus examination. 6. non-study eye bcva ≥ 24 letters (equivalent to snellen visual acuity 20/320). exclusion criteria: 1. active infectious ocular inflammation in either eye; 2. proliferative diabetic retinopathy (pdr) in the study eye, with the exception of inactive, regressed pdr; 3. any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy; 4. iris neovascularization in the study eye; 5. uncontrolled glaucoma, or history of glaucoma surgery; 6. aphakia in the study eye; 7. history of vitrectomy in the study eye; 8. history of panretinal laser photocoagulation (prp) in the study eye 6 months prior to the screening, or possibly need panretinal photocoagulation of the study eye during the study; 9. liver, kidney dysfunction; 10. history of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases.
evaluation of v.a.c. veraflo cleanse choice™ dressing using normal saline to promote increased healthy wound bed tissue

Conditions: Wound; Wound Heal; Wounds and Injuries; Granulation Tissue; Negative-pressure Wound Therapy

Summary: the study goal is to evaluate the ability of the v.a.c. ulta™ negative pressure wound therapy system and v.a.c. veraflo cleanse choice ™ (vfcc) dressing system with saline as an irrigant in increasing viable tissue in full thickness wounds (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) with difficult to manage bioburden and slough.


Eligibility criteria:
inclusion criteria: 1. is anticipated to be hospitalized for the duration of treatment. 2. is ≥22 years of age or their legally authorized representative is able to provide informed consent. 3. has a full thickness wound (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) measuring ≥4cm in length and ≥4cm in width (before removal of eschar at the bedside) excluding undermining/tunneling. 4. has, in the opinion of the investigator, no more than 2/3 of the visible wound bed surface area considered to be clean, healthy, and viable. if eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed. 5. has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days). exclusion criteria: 1. has been diagnosed with malignancy in the wound. 2. has untreated osteomyelitis. 3. has an untreated systemic infection. 4. has active cellulitis in the peri wound area. 5. has a known allergy or hypersensitivity to study materials: dressing and/or dressing components such as acrylic adhesives or polyurethane. 6. has, in the opinion of the investigator, a clinically significant condition that would impair the subject's ability to comply with the study procedures. 7. has had radiation directly to the wound. 8. has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the investigator's interpretation of the subject's medical history. 9. has eschar in the wound that cannot be removed by beside or sharp and/or mechanical debridement. 10. is participating in another interventional clinical trial for the duration of the study. 11. has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities. 12. has inadequate hemostasis at the wound site, as determined by the investigator.
xbox kinect promote physical fitness and lean mass in severely burned children

Conditions: Burns

Summary: the outcome measures included quadriceps muscle strength as measured using an isokinetic dynamometer, lbm is measured by dexa and cardiopulmonary fitness was assessed by measuring vo2 peak during a standardized treadmill exercise test using the modified bruce protocol. all outcome measures were evaluated immediately after discharge as baseline and after 12 weeks of intervention.

forty healed pediatric burn patients (24 boys and 16 girls), aged 10 - 15 years, were enrolled from the outpatient clinic in the faculty of physical therapy, cairo university, egypt. the inclusion criteria were: total body surface area (tbsa) of 40-60%, being ambulatory without an assistant. the exclusion criteria included metabolic disorders, neuropathy, visual or vestibular disorders, amputation, participation in another study, any adverse medication reactions, history of epilepsy, loss of balance, and lower or upper limb deformity. all patients received similar standard medical care and treatment from the time of admission until the time of discharge. total burn surface area was assessed by the "modified lund and browder charts" method during excisional surgery immediately following hospital admittance. informed written consent was obtained from each patient's guardian prior to enrollment. all procedures were approved by the ethical committee of the faculty of physical therapy, cairo university, giza, egypt. after consent was obtained, patients were randomly assigned to standard of care group (soc) or xbox training group (xbox). the xbox group participated in a 12-week of routine physiotherapy program supplemented with xbox training program (n=20). in contrast, the soc group participated in the routine physiotherapy program (n=20). a normal activity of daily living (adl), diet and patient's lifestyle were maintained for all participants as much as possible.

Eligibility criteria:
inclusion criteria: * total body surface area (tbsa) of 40-60%. * being ambulatory without an assistant. exclusion criteria: * metabolic disorders.neuropathy. * visual or vestibular disorders. * amputation. * participation in another study. * history of epilepsy. * loss of balance. * lower or upper limb deformity.

Keywords: lean body mass vo2 peak muscle strength enjoyment severely burned children xbox kinect
hnfo with or without helmet niv for oxygenation support in acute respiratory failure pilot rct

Conditions: Acute Hypoxemic Respiratory Failure

Summary: this randomized control trial will directly compare helmet non-invasive ventilation (niv) combined with high flow nasal oxygen (hfno) versus hfno alone in patients with acute hypoxemic respiratory failure (ahrf).

this is a pilot multicentre, concealed, stratified, permuted block randomized controlled trial enrolling patients with ahrf who are admitted to the intensive care unit. patients with imminent need for intubation, or a contraindication to study interventions will be excluded. patients will be randomized to receive either (1) sessions of at least 12 hours per day of helmet niv oxygen interspersed with hfno or (2) hfno alone over at least 2 calendar days. participants will be followed to hospital discharge or 60 days, with an additional quality of life assessment via telephone interview 6 months after enrolment.

Eligibility criteria:
inclusion criteria: 1. intensive care unit admission (orders written) 2. age ≥18 years 3. hypoxemic acute respiratory failure for at least 1 hour and still present at time of screening for eligibility (symptom onset during last 14 days) with the following: 1. respiratory rate \>21bpm or clinical evidence of increased work of breathing and 2. documented hypoxemia defined as any one of: i. pao2:fio2 \ = 0.4 or higher by venturi mask, tavish mask 10 litres / minute, or any non-invasive oxygenation strategy 4. not already intubated or with tracheostomy exclusion criteria: 1. already on hfno or other non-invasive ventilation strategy at fio2\>=0.4 for the last 24 hours in the icu. 2. immediate need for intubation (e.g., inadequate airway protection or refractory hypoxemia or cardiopulmonary arrest, massive hemoptysis, etc) 3. extubated in the icu within past 72 hours 4. clinician deems that face mask niv is indicated to treat a primary diagnosis of hypercapnic respiratory failure or acute congestive heart failure 5. known neuromuscular disease 6. patients being transitioned to palliative care or unlikely to survive more than 24 hours 7. icu discharge is planned or anticipated on the day of screening 8. previously enrolled in this trial 9. trauma patients who remain in a cervical spine collar at the time of recruitment or who have upper limb/torso fractures that would preclude them from safe application of the helmet 10. clinician decision that positive pressure to face and/or nasal pharynx is a contraindication (eg. transphenoidal surgery, basal skull fracture etc.)

Keywords: high flow nasal oxygen helmet non invasive ventilation
c11-sodium acetate pet/ct imaging evaluation in brain glioma, post therapy necrosis and pseudo-progression

Conditions: Gliomas

Summary: this study will investigate how well carbon acetate pet/ct imaging helps to correctly identify recurrent tumor versus post treatment effects (radionecrosis) in patients with previously treated high grade brain gliomas.

the study is designed to investigate the effectiveness of carbon acetate pet/ct (ac pet)in terms of its ability to distinguish between radionecrosis/pseudo-progression and viable tumor in patients previously treated with surgery and radiation for high grade glioma brain tumors. eligible patients with biopsy proven high grade gliomas (who grades 3 and 4) status-post prior cranial irradiation for this tumor; age 18 to 70; ecog/zubrod of 0-2, no other contraindications to trial entry, and a post-irradiation cranial mri or ct demonstrating an enhancing lesion of uncertain etiology (not biopsied) will be treated with at least two weeks of steroidal therapy. responders to steroidal therapy will be classified as either pseudo-progression (if asymptomatic) or radionecrosis (if symptomatic). non-responders (those who do not respond clinically, radiographically, or both) will be referred for an fdg pet/ct and initial ac pet/ct within 3 weeks, and subsequently referred for stereotactic biopsy of their lesion followed by focal laser treatment (in the same operative setting) within 3 weeks of ac pet/ct. specific goals/questions: 1. what is the yield (sensitivity, accuracy, positive and negative predictive value) of state-of-the-art pet/ct with c-11 acetate in detecting recurrent disease versus post treatment effects and pseudo-progression in this patient population? 2. how does the performance of pet with c-11 acetate compare with that of pet using f-18 fluorodeoxyglucose (fdg-pet) and with that of mri? 3. evaluate the optimal timing for post injection imaging.

Eligibility criteria:
inclusion criteria: * patients age 18-70 * pathologically confirmed world health organization (who) grade 3 or 4 glioma * ecog/zubrod 0-2 * prior external beam radiotherapy to 59.4-60 gray by 1.8-2 gy fractions * post-radiotherapy contrast-enhanced cranial mri obtained at least 6 weeks after the completion of external beam radiotherapy shows enhancing anomaly (recurrent/progressive tumor versus pseudo-progression versus radionecrosis) * patient completed at least a two week course of palliative steroid therapy for this enhancing anomaly * no prior designated therapy other than steroids for presumed radionecrosis or recurrent tumor * patient with no clinical and/or radiological response to steroid therapy * patient eligible for stereotactic brain biopsy * patient eligible for focal laser therapy exclusion criteria: * patients under the age of 18 years * claustrophobic patients

Keywords: glioblastoma high grade brain tumors recurrent pseudo-progression radionecrosis carbon acetate c11 aceate pet positron emission tomography